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STUDY "BRAVE DREAMS": Testing the processing directed by prof. Paolo Zamboni
The Ethics Committee of Ferrara has approved the experimental protocol of randomized controlled trials to evaluate clinical efficacy and safety of the intervention of unblocking the extracranial veins in patients with multiple sclerosis and diagnosis of "chronic cerebrospinal venous insufficiency (CCSVI ) called BRAVE DREAMS.
The trial will involve about 550 patients, about 10-12 clinical centers, with a double-blind procedure.
The study includes a comparison of surgery versus phlebography with venous angioplasty. a control treatment that is only performed phlebography. Eligible patients are aged 18-65 years, with MS defined according to the criteria of McDonald's and with a confirmed diagnosis of CCSVI.
The study has two primary endpoints:
a) clinical (improvement / stability / deterioration in a synthetic functional endpoint) at 12 months
b) MRI (active lesions at 12 months).
The study is intended as a multi-center, with availability in the centers of clinical skills and equipment needed in order to participate in the study. It is expected to recruit about 550 patients. The duration of the planned follow-up is 12 months. Evaluations concerning the follow-up will be conducted in a blinded fashion.
List of centers that sent the request to join the study for experimental angioplasty in patients with MS and CCSVI (study BRAVE DREAMS)
A committee will evaluate the credentials of these centers in making this site known as the Centres have completed the training phase and become operational for the selection of patients who want to join.
Hospital of Busto Arsizio - Milano - Dr. Anthony Tori
Bergamo Hospital - Dr. Rottoli Mariarosa
Cannizzaro Hospital Catania - Dr. Maria Luisa Mandalà
Vicenza Hospital Health Units 6 - Dr. Domenico Soldier
Ospedale Maggiore of Novara of Charity - Dr. Maurizio Leone
Vito Fazzi Hospital of Lecce - Dr. Francesca De Robertis
Hospital - University of Ferrara - Bellaria Hospital in Bologna (Centre National Coordinator. PI Prof Paolo Zamboni) - Dr. Fabrizio Salvi
Local Health Unit of Ravenna - Dr. Fabrizio Rasi
Hesperia Hospital, Modena - Dr. Oscar Maleti
Hospital Valduce Como - Dr. Mario Guidotti
Neurological Institute Carlo Besta of Milan - Dr. Paolo Confalonieri
CRESM University Hospital San Luigi di Orbassano - Torino - Dr. Antonio Bertolotto
Ospedale SS Annunziata Chieti - Prof Alessandra Lugaresi
Azienda Ospedaliera San Salvatore di Pesaro-Marche United Hospitals North - Dr. Cristiana Taus
Provincial Hospital of Macerata - Dr. Eugenio Pucci
University of Trieste - Prof Zorzon Marino
Company ULS 16 of Padova - Dr Giampiero Avruscio
IRCCS Policlinico S. Donato Milano - Prof. Giovanni Meola
AOOR Villa Sofia-Brain-PALERMO - Dr. Salvatore Cottone
What does BRAVE DREAMS?
It literally means BRAVE DREAMS. In reality English is the abbreviation for Brain Venous Drainage Exploited Against Multiple Sclerosis, which translated means "Exploiting the venous drainage of multiple sclerosis."
For the training of legal professionals in the field CCSVI, to contact the point of listening to the Hospital of Ferrara CCSVI
click here: http://www.ccsvi-sm.org/?q=node%2F3